Director, Medical Safety Assessment Physician

Working with Us Challenging Meaningful Life-changing Those aren t words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here uniquely interesting work happens every day in every department From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it You ll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams Take your career farther than you thought possible Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives Read more Lead safety activities and benefit-risk strategies for assigned BMS compounds program and chair the product Safety Management Team s Oversee Prepare and or Review aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings Lead team in the evaluation management of signals emerging from any data source Develop strategy for signal evaluation and document outcome Lead safety labeling activities for assigned products program Act as the Safety Subject Matter Expert for input to regulatory product labeling Participate Provide input at cross-functional labeling team meetings and provide regional safety labeling support Lead process improvement projects Assist the MSA Therapeutic Area TA Head Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS R D and WWPS Support the EU Qualified Person for Pharmacovigilance PV or other regional or local Qualified Person for PV relative to issues relating to assigned products Provide input to R D publication strategy plan ensure safety input to publications presentations Actively drive safety strategy preparation and Represent WWPS at Health Authority HA and Data Monitoring Committee DMC meetings Ensure that the above tasks are performed in the most efficient manner possible commensurate with quality accuracy and timeliness and in accordance with current global regulatory requirements and BMS cost effectiveness goals Promote collegiality and teamwork among peers Mentor Support colleagues as a positive change agent General Product Support Lead safety activities and benefit-risk strategies for assigned BMS compounds and chair the products SMT s Oversee Prepare and or Review aggregate safety review documents eg Development Safety Update Reports DSUR Periodic Benefit-Risk Evaluation Reports PBRER and safety sections of relevant clinical trial documents eg protocols clinical study reports CSR investigator brochures IB informed consent forms ICF and regulatory filings eg clinical trial applications CTA marketing authorization applications MAA Lead team in evaluation management of signals emerging from any data source eg case-series literature review Health Authority HA claims database Document by Safety Topic Review Signal Report or other means of communication Lead safety labeling activities for assigned products Support Safety input for regulatory product labeling Participate Provide input at cross-functional labeling team meetings and provide regional safety labeling support Support the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products Support R D publication strategy plan ensure safety input to publications presentations Clinical Development Act as the global safety lead for assigned compounds in development Provide safety lead support for global submission document production Review draft summary documents Lead medical safety development and execution of benefit-risk management strategies for assigned products Provide safety input to clinical development plans study protocols amendments IB statistical analysis plan SAP ICF CSR responses to HA or institutional review board IRB ethics committee EC queries Lead development of safety risk language risk management strategy pre-filing safety activities including safety table shells integrated safety data review integrated safety summary document review safety-focused publication development Perform medical safety review of development update safety reports annual reports and other periodic safety submissions Support safety strategy preparation for pre-submission meetings Advisory Committee meetings Scientific Advice meetings DMC meetings etc Postmarketing Support Act as the safety lead for assigned marketed compounds and support global postmarketing safety activities and submissions Provide medical safety benefit-risk input for safety aggregate reports product renewal submissions postmarketing study documents and reports responses to HA queries Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned products Lead safety signal evaluation management Prepare and review reports on safety signals ie Safety Topic Reviews Signal Reports and ad hoc regulatory responses Provide postmarketing safety study guidance to other groups including epidemiology and medical affairs including but not limited to investigator-sponsored research ISR epidemiology studies and non-interventional safety studies Ensure safety labeling adequately reflects emerging postmarketing safety profile Department Activities Lead process improvement projects Assist the MSA TA Head Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS R D and WWPS Support preparation for regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations guidelines and mandates Assist the team and senior management in all forms of issue management and crisis management Liaise with all TA staff and maintain an effective and collaborative patient safety team Support hiring orientation Cross-Functional Activities Provide input to strategic plans for safety differentiation of BMS products Prepare and Provide training to BMS employees on product safety profiles issues Act as WWPS liaison for assigned products with BMS functions Legal BD Operations Marketing etc Support manufacturing quality Co-Author integrated health hazard assessments Develop communications of safety data interpretation to BMS and external parties globally Education Experience Licenses Certifications MD equivalent required Postgraduate qualification or experience in internal medicine immunology oncology or related specialty desirable Other relevant experiences accomplishments considered such as roles in clinical research observational research clinical practice experience 3 years in PV or relevant pharmaceutical or biomedical field eg Medical Clinical Regulatory is strongly preferred Other relevant experiences accomplishments considered such as roles in clinical research observational research clinical practice experience Specific Knowledge Skills Abilities Understanding of the drug development process Knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product Proficient ability to leverage the range of available tools to investigate safety concerns including the science of observational research Understanding of regulatory requirements for safety assessment and action Strong scientific analytical reasoning skills Ability to work on multiple projects in parallel Excellent attention to detail Behavioral competencies necessary to work and lead within a complex matrix environment Excellent verbal and written communication skills If you come across a role that intrigues you but doesn t perfectly line up with your resume we encourage you to apply anyway You could be one step away from work that will transform your life and career Uniquely Interesting Work Life-changing Careers With a single vision as inspiring as Transforming patients lives through science TM every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential site-by-design field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100 of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50 onsite at your assigned facility For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation adjustment prior to accepting a job offer If you require reasonable accommodations adjustments in completing this application or in any part of the recruitment process direct your inquiries to Visit to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff customers patients and communities As a result the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations